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There’s an aisle at the supermarket that has a sign above it that reads “ADULT CEREALS”. Every time I see it, I snigger inwardly at the thought of sexually explicit cornflakes. (Pornflakes. You’re welcome.) It’s not big, and it’s not clever: I know that. But all these years living in south Manchester have taught me to grab whatever slivers of humour one can from life.

Anyway… A friend’s FB feed this morning pointed me in the direction of this: a page on Boredpanda showing some of the best entries to the 2016 Birth Photography competition. (Yeah: I know. I had no idea, either.)

I guess that birth photography is a bit of a niche field. The one that won “Best in Category: Labour” is, for my money, a brilliant picture. Some of the compositions are astonishingly good – but then, come to think of it, childbirth isn’t exactly a surprise, so I suppose that if you’re going to invite someone to photograph it, they’re going to have plenty of time to make sure that the lighting is right.

A second thought that the pictures raise is this: no matter how much people bang on about the miracle of birth… well, nope. Look at the labour picture again. I can’t begin to express how glad I am that that’s never going to happen to me; and I’m even more convinced than I was that I don’t want to play any part in inflicting that on another person.

But my overriding response is something in the realm of astonishment that some of the pictures are blanked out as having “mature content”.

One of the most important responsibilities of a clinical project lead at a biotech company or an academic research team is to generate clinical trial protocols. The protocol dictates how a trial will be conducted and details background information on prior research, scientific objectives, study rationale, research methodology and design, participant eligibility criteria, anticipated risks and benefits, how adverse events will be handled, plans for statistical analysis, and other topics. Many protocol authors use as a starting point a “standardised” protocol template from their funder or institution. These templates often provide standard language, and sections for customisation, sometimes with various “pick-and-choose” options based on the nature of the research. They inevitably cover each of the key topics listed above, but often fail to include ethical principles and considerations beyond the regulatory requirement of informed consent. Indeed, the process of protocol writing has traditionally focused on scientific detail, with ethical analysis often left to institutional review boards (IRBs) and research ethics committees (RECs); unfortunately, robust discussion of specific ethical issues is often absent from clinical trial protocols.

When IRBs and RECs convene to review protocols, they are expected to evaluate whether the study will adequately protect enrolled participants. When the protocol fails to address potential ethical concerns explicitly, reviewers are left to speculate: did the investigator consider the concern, but dismiss it as not relevant in this particular context; did the investigator fail to understand the concern; does the investigator have an appropriate plan in place to resolve the concern, but has left it unstated in the protocol? This uncertainty can contribute to delays as reviewers debate among themselves, and can require lengthy back-and-forth with researchers, including series of protocol revisions and re-reviews until clarity is established. In some cases, it may also be that reviewers with less experience or expertise fail to identify an ethical concern that has not been brought to their attention in a protocol. more…

On a number of occasions, I have been asked by early career ethicists about the move from ethics to law, or the wisdom of seeking a legal qualification to supplement their ethical knowledge. In the UK, this can be achieved remarkably quickly. This blog post is an answer to those questions, based only on my own experiences.

In 2008, I was a lecturer in medical ethics and law at St George’s, University of London. I had no legal training, and felt uncomfortable teaching law to medical students. Some of the graduate students were former lawyers and it must have been obvious to them that the limits of my legal knowledge extended no further than the PowerPoint slide.

That year, an old school friend, a solicitor, encouraged me to become a lawyer. “I can imagine calling you ‘My learned friend‘ in court”, he said. And so the seed was planted, and with each soul-sapping marking session, and each article published and quite unread, the seed grew until, in 2009, I resigned from my lectureship to study on the law conversion course, now called the Graduate Diploma in Law (GDL). more…

One of those things that’d simply never occurred to me before was highlighted a few days ago in a story on Buzzfeed: how do you reconcile Ramadan fasting with recovery from an eating disorder? Indeed: can you reconcile them at all?

“Food is obviously a big part of the holy month,” Sofia says. “Usually after breaking fasts, my family have bigger meals than usual, my mum cooks a lot of extravagant Pakistani dishes for iftar. It’s also a time when my extended family tend to visit more, or we go to the mosque and eat there.

“It’s really difficult to eat in public, especially because I’m still uncomfortable around a lot of foods. And what people usually don’t understand is how seeing all that food can make you feel so pressured. Last Ramadan I remember having to force myself to eat because everyone kept telling me to – and I couldn’t say no to them. When we came back from the mosque, I spent most of the night crying, because I felt I had no control.”

[…]

She adds: “I know in my head that I need to stick to the diet and do what my doctor says. But it’s still uncomfortable preparing food while my family aren’t allowed to eat or drink.” At times she “feels guilty while she’s eating”, she says, and there are moments when she’s tempted to go back to fasting again.

How central is the not-eating to Ramadan? I mean: I know that there’re exemptions for things like medical conditions; but is there a mechanism for people not so much to be exempted, but to make an equivalent sacrifice? Is fasting valued in itself, or because of what it symbolises? If the latter, than some sort of substitution would seem possible without that counting as an exception. If the former, then that wouldn’t be so clear.

Either way, the article suggests that part of the problem here is that there simply isn’t the support. Inasmuch as that anorexic Muslims will be a minority of a minority, I suppose that that’s not surprising – and it’s compounded by apparent misunderstanding in south Asian communities. But it’s no less worth noting for that.

Incidental findings in brain imaging research are common. Investigators can discover these unexpected findings of potential medical significance in up to 70% of their research scans. However, there are no standards to guide investigators as to whether they should actively search for these findings or which, if any, they should return to research participants.

This complex ethical issue impacts many groups in brain imaging: participants and parents of child participants who may desire relevant health information, but alternatively may suffer from anxiety and financial burden; investigators who must ethically grant their participants autonomy, but who also may suffer from budget and personnel restrictions to manage the review and report of these findings; Institutional Review Board (IRB) members who must provide ethical oversight to imaging research and help mandate institutional standards; and health providers who must interface with their patients and assist with follow up care when necessary.

Our research study shows these groups share some ideas on the ethics of returning incidental findings – “the researcher has an ethical responsibility or obligation to tell a subject that there’s something there, however they do it, but just inform the subject, even though it’s not part of the research” – yet also acknowledge the inherent risk in reporting medical research information. As one of our IRB members commented, “I mean [in regards to withholding findings] one reason would be to protect the patient from doing something stupid about them.”

When participants are asked about incidental findings, they consistently state that they want to receive all information pertinent to their health. Research participants want to make their own medical decisions and feel investigators have a responsibility to keep them informed.

However, it is clear from our research that participants do not always understand the difference between a brain scan for research purposes and a clinical scan. The incidental finding reports that they receive include personal health information, written in medical jargon, discovered during a clinical procedure that may have immediate or long term medical significance. Because of this crossover between conducting research and sharing health information, participants may overestimate the clinical utility of the reported research information. This is a challenge for investigators whose role is to conduct research, not to diagnose participants or offer findings with clinical certainty. Participant assumptions otherwise have the potential to cause downstream legal complications for the research institution.

It is necessary to understand the impact on all parties involved in the process of disclosing incidental findings to determine appropriate management policy. This challenging task should not be underestimated as these groups think differently about the balance between risk and benefit based on their role in this process, whether they be a research participant, a research investigator, an IRB member or a health provider. Overall there is an ethical demand to manage and report unexpected findings discovered in brain imaging research; finding a way to do this while minimizing negative impact for all involved is important.

How many animals are experimented on in laboratories? It’s a simple question, the answer to which provides a basic parameter to help us wrap our heads around the increasingly controversial and ethically harrowing practice of locking animals in cages and conducting harmful procedures on them that are often scary, painful, and deadly. Yet ascertaining the answer in the United States – the world’s largest user of animals in experiments – is surprisingly difficult.

In the eyes of the US Animal Welfare Act (AWA) – the single federal law that governs the treatment of animals used in experimentation – not all animals are created equal. Mice, rats, and birds bred for experimentation, and all cold-blooded animals – estimated by industry to comprise more than 95 percent of all animals used – are all unscientifically and dumbfoundingly excluded from the AWA’s definition of “animal”. Orwell cheers from his grave while Darwin rolls in his.

Leaving aside the question of whether mice and rats should be categorized as vegetable or mineral, the exclusion of these animals from the AWA also results in a dearth of data on the most widely used species, as the only figures on animal use in US laboratories that are systematically collected, organized, and published by the government are on AWA-regulated species. more…

On 11th March Nadine Montgomery won her case before the UK Supreme Court to gain compensation for the failure of her obstetrician to warn her of risks associated with the vaginal delivery of a large infant – a risk which she would have averted by requesting a caesarean section.[1] Shortly after his birth, her son was diagnosed with cerebral palsy and a brachial plexus injury, resulting from the occlusion of the placenta during a “very stressful” vaginal delivery.

Nadine Montgomery had diabetes, which increased her chances of giving birth to a larger than average-sized baby. This, in conjunction with her small stature (she was 5 feet tall), indicated a risk that a natural delivery would bring with it a 9-10% chance of shoulder dystocia. Were dystocia to occur, attempts to dislodge the infant’s shoulders through mechanical manoeuvres would generate a risk of occlusion of the umbilical cord resulting in death or cerebral palsy of 0.1%. According to the obstetrician, Dr McLellan, the risk of shoulder dystocia did not merit specific mention in discussions with diabetic patients, because the risk of an adverse event associated with shoulder dystocia was very small indeed.

Mrs Montgomery’s case before the UK Supreme Court hinged on the question of the nature of the obstetrician’s duty to the patient. more…

In December of last year, the Centers for Disease Control and Prevention (CDC) released its proposed new recommendations on male circumcision. The verdict? Circumcision provides major benefits with minimal risks. These benefits accrue whether circumcision is performed in infancy or later on in life. Circumcision may even help to stem the HIV epidemic in the United States. Perhaps you should do something about that foreskin.

The resulting firestorm was swift, fierce, and predictable. Critics of infant circumcision blasted the CDC, accusing it of trampling the child’s right to bodily integrity. Defenders of circumcision fired back, extolling the prophylactic virtues of the procedure. Subtle questions about autonomy were lost in the maelstrom. Yet these questions lie at the heart of the conflict, as I suggest in a new article.

Let’s look more closely at the debate over circumcision and HIV. Defenders of circumcision tout studies showing that circumcision reduces female-to-male sexual transmission of HIV. Critics retort that there exists a more effective and less drastic means of achieving the same end – namely, condoms. Perhaps, concede the defenders, but many men don’t use condoms consistently and effectively – hence the enduring problem of STIs. That’s their choice! say the critics. So? say the defenders. And so on, ad infinitum.

The foregoing squabble is essentially a disagreement about autonomy. more…

In the Netherlands, requests for euthanasia are not uncommon. A physician who grants a request for euthanasia in the Netherlands is not prosecuted if the criteria for due care (described in the Euthanasia Act) are met. An example of one of these criteria is the presence of unbearable suffering without prospect of improvement. Almost all physicians in the Netherlands can conceive of situations in which they would perform euthanasia. However, each request for euthanasia calls for careful deliberation. When confronted with a request, a physician needs to judge the situation from two perspectives. The first is the legal perspective; would this case meet the criteria for due care? To judge this, a physician can fall back on the description of the Euthanasia Act and receives help from a consulting physician. The second perspective is personal; how does the physician feel about performing euthanasia in this situation? Is it in line with his personal values?

Our study shows that cause of the patient’s suffering is one of the aspects that influence the physician’s decision on euthanasia. This is interesting, because the Dutch euthanasia act does not make a distinction between different diseases. In case of suffering with a clear physical cause like cancer, most physicians can conceive of performing euthanasia. However, there are also people who request for euthanasia without suffering from a severe physical cause. In these cases, there are not many physicians who would consider complying with this request. As a consequence, people suffering from a psychiatric disease and early stage dementia with a euthanasia wish will rarely find a physician who would grant their euthanasia request. The same is true for people who are tired of living but who do not suffer from a severe physical disease. Also, most physicians will not consider following advanced euthanasia directives asking for euthanasia in case of advanced dementia.

Concluding, while most Dutch physicians can conceive of granting requests for euthanasia from patients suffering from cancer or other severe physical diseases, this is not the case in patients suffering from psychiatric disease, dementia or being tired of living. This distinction is partly related to the criteria for due care. For instance, some physicians describe that it is impossible to determine the presence of unbearable suffering in a patient with advanced dementia. Other explanations for the distinction are not related to the criteria for due care. For instance, it is understandable that physicians do not agree with performing euthanasia in a patient with advanced dementia who does not fully understand what is happening, even if the patient has a clear advanced euthanasia directive.

Each physician needs to form his or her own standpoint on euthanasia, based on legal boundaries and personal values. We would advise people with a future wish for euthanasia to discuss this wish with their physician in time, and we would advise physicians to be clear about their standpoint on the matter. This can help to prevent disagreement and disappointment.

It turns out that the version of the Medical Innovation Bill about which I wrote this morning isn’t the most recent: the most recent version is available here. Naïvely, I’d assumed that the government would make sure the latest version was the easiest to find. Silly me.

Here’s the updated version of §1(3): it says that the process of deciding whether to use an unorthodox treatment

(c) consideration of any opinions or requests expressed by or on behalf of the patient;

(d) obtaining any consents required by law; and

(e) consideration of all matters that appear to the doctor to be reasonably necessary to be considered in order to reach a clinical judgment, including assessment and comparison of the actual or probable risks and consequences of different treatments.

So it is a bit better – it seems to take out the explicit “ask your mates” line.

However, it still doesn’t say how medics ought to weigh these criteria, or what counts as an appropriately qualified colleague. So, on the face of it, our homeopath-oncologist could go to a “qualified” homeopath. Or he could go to an oncologist, get told he’s a nutter, make a mental note of that, and decide that that’s quite enough consultation and that he’s still happy to try homeopathy anyway.

So it’s still a crappy piece of legislation. And it still enjoys government support. Which does, I suppose, give me an excuse to post this: